CA2163131A1 - Expandable urethral plug - Google Patents
Expandable urethral plugInfo
- Publication number
- CA2163131A1 CA2163131A1 CA 2163131 CA2163131A CA2163131A1 CA 2163131 A1 CA2163131 A1 CA 2163131A1 CA 2163131 CA2163131 CA 2163131 CA 2163131 A CA2163131 A CA 2163131A CA 2163131 A1 CA2163131 A1 CA 2163131A1
- Authority
- CA
- Canada
- Prior art keywords
- housing
- urethra
- shape
- plug
- bladder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
- A61F2/0013—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body inflatable
Landscapes
- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
A urethral plug (10) possessing a contracted diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder. In a first embodiment, the plug (10) comprises a cooperating housing and inner member lying in coaxial engagement. A larger diameter is achieved by mechanical deployment of the inner member, resulting in the changing of the shape of the housing, or in another embodiment, the changing of the shape of the inner member. In a further embodiment the urethral plug comprises a housing comprised of material which undergoes automatic expansion when exposed to temperature. The urethral plug (10) assumes a non-expanded first condition when exposed to a temperature approximately less than that of a mammalian body, and assumes an expanded second condition when exposed to a transition temperature of approximately the body temperature of a mammal.
Description
2 1 ~ 3 1 3 1 - ~ ~ PCT/US94/05536 EXPANDABLE URETHRAL PLUG
BACKGROUND OF THE INVENTION
Field of the invention ; The present invention relates to a novel plug which is in-serted into the urethra to control urinary incontinence.
Description of the Prior Art Urinary stress incontinence is defined as the involuntary loss of urine when the pressure within the urethra exceeds the maximum urethral pressure required for maint~; ni ng closure.
While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child bearing age and beyond.
There are in existence many methods used to address the problem of incontinence. Bladder neck suspension surgery, wherein the neck of the bladder is reduced by suspending the bladder, is perhaps the most desirable way to treat incontinence, especially in younger patients. However, there are numerous risks associated with such surgery, notwithstanding the expense.
For some patients, surgery is not recommPn~ed for medical or other reasons, and for those with mild incontinence surgery is not an appropriate solution.
Also in existence are a variety of devices for controlling urinary incont;nence. Many of these devices require surgery for implantation, and of these surgically implanted devices, there are two distinct types: non-manipulable devices and manipulable devices. One such non-manipulable device, described in United States Patent No. 4,019,499, is a capsule filled with a variable amount of fluid. The capsule is surgically implanted between supporting tissue and the urethra to exert an occluding force thereon. A similar, non-manipulable capsule implant is described in United States Patent No. 3,789,828. However, this device has ties extending therefrom to aid in fiber ingrowth, thus providing mechanical stability to the capsule. One problem associated with this device is the risk of fluid leakage. In ad-WO94/26215 21 6 3 l 31 ~ PCT~S94105536 dition to problems with leakage, severe tissue damage may resultfrom the unnatural method in which such devices regulate incon-tinence.
Other surgically implanted devices exist which are manipul-able. These devices provide the wearer with the ability to selectively control the operation of the device via manually operable elements implanted in the tissue surrounding the urethra. United States Patent No. 4,428,365, and United States Patent No. 4,846,784 each disclose an indwelling device having an inflatable chamber with an attached tubing and an inflation bulb. The wearer may manually adjust the pressure exhibited by the inflatable member on the urethra, simply by squeezing the tissue encasing the bulb. These devices, however, often produce thickening and scarring of surrounding tissue, making their usefulness questionable. Additional adverse effects associated with surgically implanted indwelling devices, whether non-manipulable or manipulable in nature, are encrustation, irritation and infection.
There are also known in the art certain indwelling devices that do not require surgical implantation. These devices are in-serted by a physician through the urethral orifice and allow the wearer to void either past or through the device. An example of such a device is disclosed in United States Patent No. 4,850,963 in which a physician inserts a bolus of ferromagnetic material through the urethra and into the bladder. The bolus rests at the juncture of the bladder and urethra and is moved for bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative. Another example of this type of indwelling device is the prestressed capsule disclosed in United States Patent No. 4,457,299. The capsule is inserted by a physician within the lower interior of the urethra and is set at a prestressed pressure slightly above involuntary pressure. When the urine pressure exceeds the preset pressure of the capsule, the capsule deforms allowing urine to flow around the device. This device, however, has no feature to prevent W09412621~ 2 1 6 3 1 3 1 PCT~S94/OS536
BACKGROUND OF THE INVENTION
Field of the invention ; The present invention relates to a novel plug which is in-serted into the urethra to control urinary incontinence.
Description of the Prior Art Urinary stress incontinence is defined as the involuntary loss of urine when the pressure within the urethra exceeds the maximum urethral pressure required for maint~; ni ng closure.
While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child bearing age and beyond.
There are in existence many methods used to address the problem of incontinence. Bladder neck suspension surgery, wherein the neck of the bladder is reduced by suspending the bladder, is perhaps the most desirable way to treat incontinence, especially in younger patients. However, there are numerous risks associated with such surgery, notwithstanding the expense.
For some patients, surgery is not recommPn~ed for medical or other reasons, and for those with mild incontinence surgery is not an appropriate solution.
Also in existence are a variety of devices for controlling urinary incont;nence. Many of these devices require surgery for implantation, and of these surgically implanted devices, there are two distinct types: non-manipulable devices and manipulable devices. One such non-manipulable device, described in United States Patent No. 4,019,499, is a capsule filled with a variable amount of fluid. The capsule is surgically implanted between supporting tissue and the urethra to exert an occluding force thereon. A similar, non-manipulable capsule implant is described in United States Patent No. 3,789,828. However, this device has ties extending therefrom to aid in fiber ingrowth, thus providing mechanical stability to the capsule. One problem associated with this device is the risk of fluid leakage. In ad-WO94/26215 21 6 3 l 31 ~ PCT~S94105536 dition to problems with leakage, severe tissue damage may resultfrom the unnatural method in which such devices regulate incon-tinence.
Other surgically implanted devices exist which are manipul-able. These devices provide the wearer with the ability to selectively control the operation of the device via manually operable elements implanted in the tissue surrounding the urethra. United States Patent No. 4,428,365, and United States Patent No. 4,846,784 each disclose an indwelling device having an inflatable chamber with an attached tubing and an inflation bulb. The wearer may manually adjust the pressure exhibited by the inflatable member on the urethra, simply by squeezing the tissue encasing the bulb. These devices, however, often produce thickening and scarring of surrounding tissue, making their usefulness questionable. Additional adverse effects associated with surgically implanted indwelling devices, whether non-manipulable or manipulable in nature, are encrustation, irritation and infection.
There are also known in the art certain indwelling devices that do not require surgical implantation. These devices are in-serted by a physician through the urethral orifice and allow the wearer to void either past or through the device. An example of such a device is disclosed in United States Patent No. 4,850,963 in which a physician inserts a bolus of ferromagnetic material through the urethra and into the bladder. The bolus rests at the juncture of the bladder and urethra and is moved for bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative. Another example of this type of indwelling device is the prestressed capsule disclosed in United States Patent No. 4,457,299. The capsule is inserted by a physician within the lower interior of the urethra and is set at a prestressed pressure slightly above involuntary pressure. When the urine pressure exceeds the preset pressure of the capsule, the capsule deforms allowing urine to flow around the device. This device, however, has no feature to prevent W09412621~ 2 1 6 3 1 3 1 PCT~S94/OS536
3 ' - ~C
migration of the device into the bladder. In United States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in the bladder. The patient increases his bladder pressure by means of a valsalva maneuver, and holds this pressure while the valve ; activates. Urine may then pass through the valve with the valve later returning to its closed position. This device is very complicated, expensive, difficult to manufacture and uncomfortable. Another physician-inserted device is disclosed in United States Patent No. 3,797,478. This device has an expandable collar which is inflated after insertion, by an injection of fluid therein. When it is desired to remove the device, the inflated collar is ruptured or serrated, thus expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection associated with the release of injection fluid upon removal.
Similarly, United States Patent No. 3,841,304 discloses a plug which is inserted by a physician into the urethra and subse~uently inflated to block the flow of urine. This device may be left in the body for extended periods. After insertion, the device merely requires repositioning in the urethra to permit bladder evacuation. Such a device leaves the wearer susceptible to infection, as bacteria may be introduced into the urethra during repositioning, or during indwelling time. Also, serious complications can occur upon removal, when a separate wire must be inserted therein. These devices being indwelling, are often cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection.
Also known in the art are devices capable of being inserted by the wearer into the urethra. Such devices are removed for voiding, and then reintroduced into the urethra upon completion of bladder evacuation. An example of such a device is the solid-type urethral plug, described by Neilsen, Kurt K. et al., in "The Urethral Plug: A New Treatment Modality for Genuine Uri-nary Stress Incontinence in Women" J. Urology, vol. 44, p. llOO
(l990). This device consists of one or two solid spheres located along a soft shaft, and a thin, soft plate located at the end of WO94/26215 ~. ~ PCT~S94105536 21 63~ 31 4 ~
the shaft. One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of the sphincter. In the two sphere embodiment, the second sphere is located with its midpoint at the bladder neck, and is used to assist in reducing urinary flow and pressure transmission to the urethra so that the sphincter can operate. When the patient wants to evacuate the bladder, the plug is removed, evacuation occurs, and a fresh plug is inserted. One problem associated with this device is that the patient must have three urethral closure pressure profiles performed as well as other exAmln~tions, before the device is made for the wearer.
Additional problems associated with this device include placement difficulties, lack of sealing capabilities associated therewith, inade~uate retention thereby allowing expelling and inade~uate anchoring by the plate at the meatus. In addition to such problems of inadequate placement, sealing, and retention, is the discomfort associated with insertion and removal, due to the size profile and rigidity of the spheres. The spheres of this device maintain a constant diameter during insertion, and removal.
Another "remove-to-void" device is disclosed in United States Patent No. 5,090,424, which comprises a conformable urethral plug. The body of the plug forms a cavity which is in fluid com-munication with another cavity via a check-valve. Thus, fluid may be pumped into the cavity within the urethra to provide a custom fit. This device, like many others relying on liquids or gels for expansion, relies heavily on a fluid-tight valve in or-der to maintain retention. Should valve failure occur, evacua-tion would immediately follow. There is also a chance of fluid leakage into the body of the wearer should rupture of the plug occur.
In view of the above problems associated with the prior art, an easily usable, expandable plug device of a non-fluid construc-tion, which is mechanically actuated, would be desirable to those afflicted with urinary incontinence.
OBJECTS OF THE INVENTION
One object of the invention is to provide a urethral plug wo94l26~ls 2 ~ 6 3 1 3 I rcT~ss4lo5s36 which is easily manipulated by the wearer.
Another object of the invention is to improve the degree of comfort associated with insertion and removal of a urethral plug.
- A further object of the invention is to enhance the sealing ability of a urethral plug with the urethra, bladder neck or ; bladder wall.
Another object of the invention is to stabilize the place-ment of a urethral plug at the urethral meatus, such that migra-tion into the bladder will not occur.
Still another object of the invention is to reduce the risk of infection to the wearer of a urethral plug .
Still another object of the invention is to provide a method of using a manually deployable urethral plug by patients suffer-ing from urinary incontinence.
It is yet another object of the present invention to provide a method of using a removable-to-void urethral plug which expands automatically without user intervention for retention in the body and to block the flow of urine in the urethra.
These and other objects of the invention are carried out by an expandable urethral plug having a contracted diameter for in-sertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder. In a first embodiment, the plug comprises a cooperating housing and inner member lying in coaxial engagement. A larger diameter is achieved by mechanical deployment of the inner member, resulting in the changing of the shape of the housing, or in another embodiment, the changing of the shape of the inner member. In an alternative embodiment the urethral plug comprises a member comprised of material which un-dergoes automatic expansion when exposed to temperature or li-~uid. The urethral plug assumes a non-expanded first condition when exposed to a temperature approximately less than that of a m~mm~l ian body, and assumes an expanded second condition when ex-posed to a transition temperature of approximately the body tem-perature of a m~mm~ 1 . In yet another embodiment, the expanded second condition is achieved when the urethral plug is exposed to natural bodily conditions such as, but not limited to, body WO94/26215 , f-~ PCT~S94/05~36 21 63l 31 moisture.
In each embodiment, the expansion of the plug causes a bal-loon to expand, which seals the plug to the urethral, bladder neck and bladder wall. The plug further has a meatal plate for anchoring the plug in the urethra, which preven:ts migration of both the plug and the cord into the bladder.-~ Removal of the plug for bladder evacuation, may be easily accomplished by pull-ing a cord. In accordance with a further feature of the inven-tion, there is provided a method for controlling incontinence in humans.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure lA shows a first embodiment of the urethral plug which has an expansible outer tube, in its contracted configura-tion.
Figure lB shows the first embodiment of the urethral plug in its expanded configuration.
Figure 2A shows a second embodiment of the urethral plug which has a braided mesh, in its contracted configuration.
Figure 2B shows the second embodiment of the urethral plug in its expanded configuration.
Figure 3A shows a third embodiment of the urethral plug in its contracted configuration.
Figure 3B shows the third embodiment of the urethral plug in its expanded configuration.
Figure 4A shows a fourth embodiment of the urethral plug, which is thermally expandable, in its contracted configuration.
Figure 4B shows a fourth embodiment of the urethral plug, which is thermally expandable, in its expanded configuration.
Figure 5A shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its contracted configuration.
Figure 5B shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its expanded configuration.
Figure 6 shows an end view of the meatal plate of the urethral plug of each of the above embodiments.
wo94l262ls 2 1 6 3 1 3 1 -~ PCT~S94/05536 Figure 7A shows an cross sectional view of the urethral plug.
Figure 7B shows a cross sectional view of an alternate em-bodiment of the urethral plug.
DETAILED DESCRIPTION OF THE INVENTION
Figure lA shows the urethral plug of the first embodiment 10, in its contracted configuration. The plug housing comprises a hollow, cylindrical tube 2 which is sized to be easily inserted through the orifice of the urethra. The tube 2 is made from a biocompatible material having characteristics ofcompressibility.
Attached on the periphery thereof either by thermal bonding, laminating or other means, is a sealing membrane, or balloon, 4 which is adapted to rest against the outer tube 2. At the distal end of the tube 2 is a meatal plate 6. The meatal plate 6 is adapted to anchor the urethral plug 10 at the meatus urinarius.
To carry out this function of anchoring, the meatal plate 6 is of a thickness sufficient to withstand bodily compression during wear, preferably on the order of 1 millimeter or greater. The meatal plate 6 prevents the plug 10 from passing through the orifice in the urethra ultimately leading into the bladder neck or bladder.
Figure 6 shows an end view of the meatal plate 6, which is the same as the meatal plates to be shown in future embodiments.
A portion of the meatal plate 6 is extended so as to form a tab 8 which may be grasped by the wearer for ease of removal. The meatal plate may further aid in maintaining the plug's expanded configuration during wear, by providing means for securing, such as a ball retention socket (not shown). The meatal plate 6 also has an opening 11 therein, lying within the plane of the opening of the outer tube 2.
Referring again to Figure lA, enclosed within the tube 2 is a support rod 12, which may be a hollow or a solid member. The support rod 12 has a bulb 14 at one end thereof, abutting the proximal end of the tube 2. The bulb 14 functions to hold the support rod 12 within the tube 2. The support rod 12 has a cord 16 attached at its end opposite the bulb 14, which extends WO94/26215 - - ~; PCT~S94/05536 2 1 6 3 1 3 1 ~
through the tube 2 and beyond the meatal plate 6, thus ensuring that a wearer will always be able to reach the cord 16. On the cord 16 there is preferably formed a knot 18. Although the knot 18 has been used, the attachment of any member having a diameter greater than ball retention socket 7 would suffice. The support rod 12 is preferably stainless steel, the o~ter tube 2 is preferably formed of a biocompatible thermoplastic material and the balloon 4 is preferably a biocompatible~thermoplastic elas-tomer, such as that sold under the trademark KRATON. However, any biocompatible material may be used for each of the aforemen-tioned elements, as the invention is not to be limited to those named above. Lines A-A' represents the cross sectional view of the tube 2, which will be discussed further with reference to Figures 7A and 7B.
A user inserts the plug 10 while it is in the configura-tion shown in Figure lA. Once the plug 10 has been inserted and the meatal plate 6 abuts the meatus urinarius, the plug 10 may be deployed by the wearer, upon which it achieves an expanded configuration, as set forth in Figure lB. To deploy, the wearer pulls on the cord 16 depending from the support rod 12. By pull-ing, a downward force is exerted on the cord 16 in the vertical direction, forcing the support rod 12 to slide downwardly in the tube 2 and exert a compressive force against the proximal end of the outer tube 2. The tube 2 thus expands outwardly in the horizontal direction, causing the balloon 4 to expand until the balloon forms a seal with the wall of the urethra, bladder neck or bladder. The wearer then secures the cord by sliding it through a slit (not shown) in the ball retention socket 7 located on the meatal plate 6. This causes the knot 18 to act as a stop, as the knot 18 rests within the socket 7, thereby preventing the tube 2 from returning to its contracted state (Figure lA).
The plug 10 in an expanded form as shown in Figure lB, functions to retain and block the flow of urine. When the wearer wishes to remove the plug, a simple tug on the cord 16 in a direction away from the socket 7 will cause the knot 18 to be released therefrom, thus causing the tube 2 to retract to its contracted state of Figure lA. The tube 2 thereby returns to its WO94/26215 2 ¦ 6 3 1 ~ ~PCT~S94/05536 original diameter prior to insertion, making plug removal a comfortable task. Thus, the tube 2 and balloon 4 cooperatively provide an expandable housing and the plug includes means for mechanically expanding the housing and selectively returning the housing to its non-expanded condition.
Figure 2A shows a second embodiment of the urethral plug 110 in its contracted configuration. Tube 102 is formed by a flexible braided mesh 103. Attached on the periphery thereof either by thermal bonding, laminating or other means, is a seal-ing membrane, or balloon, 104 which is adapted to rest against the tube 102. Enclosed within the tube 102 is a support rod 112, which may be a hollow or a solid member. The support rod has a bulb 114 at one end thereof, fixed to the proximal end of the tube 102. The bulb 114 functions to secure the support rod 112 within the tube 102. The support rod 112 has a cord 116 attached at its end opposite the bulb 114, which extends through the tube 102 and beyond the meatal plate 106, thus ensuring that a wearer will always be able to reach the cord 116. The cord 116 preferably has formed therein a knot 118. Although a knot 118 has been used, the att~chment of any member having a diameter greater than ball retention socket 107 would suffice. The sup-port rod 112 is preferably stainless s,teel, the outer tube 102 is preferably formed of a biocompatible thermoplastic material and the balloon 104 is preferably a biocompatible thermoplastic elastomer, such as that sold under the tr~em~rk KRATON.
However, any biocompatible material may be used for each of the aforementioned elements, as the invention is not to be limited to those named above. Lines A-A' represent the cross sectional view of the tube 102, which will be discussed further with reference to Figures 7A and 7B.
The user inserts the plug 110 while it is in the configuration shown in Figure 2A. Once the plug has been inserted and the meatal plate 106 abuts the orifice of the urethra, the plug is deployed by the wearer, upon which it achieves the expanded configuration as set forth in Figure 2B.
To deploy, the wearer pulls down on the cord 116, in a direction opposite the direction of initial insertion of the device. Thus, WO94126215 2 t 6 31 3 l : ~ PCT~S94/05~36 a compressive force is exerted in the vertical direction by the cord 116 on the bulb 114, which is transmitted from the bulb 114 to the tube 102. This force causes the braided mesh 103 to expand outwardly in the horizontal direction. The expansion of the braided mesh forms an oval projection, which projection causes the balloon 104 to expand therewith. The wearer then secures the cord 116 by sliding it through the slit (not shown) in the ball retention socket 107 in the meatal plate 106. This causes the knot 118 to act as a stop, as the knot is brought to rest within the socket 107, thereby preventing the braided mesh 103 from returning to its contracted state as shown in Figure 2A). The balloon thus retains its seal with the urethral, bladder neck or bladder wall and functions to block the flow of urine.
When the wearer wishes to remove the plug , a simple tug on the cord 116 in a direction away from the socket 107 will cause the knot 118 to be released therefrom, thus causing the braided mesh 103 to retract. The tube 102 thereby returns to its original diameter prior to insertion, making plug removal a com-fortable task.
Figure 3A shows the plug 210 of the third embodiment of the present invention in its contracted state. An outer tube 202 has a plurality of elongated apertures 201 formed therein. Line A-A' represents the cross sectional view of the outer tube 202 which will be discussed further with reference to Figures 7A and 7B.
Attached to the periphery of the outer tube 202, is a sealing membrane, or balloon 204 which is its pre-insertion configuration (Figure 3A), is adapted to rest against the outer tube 202. At the proximal end of the outer tube 202 is an end cap 214. At the distal end of the outer tube 202 is a meatal plate 206 which has a thickness sufficient to prevent compression thereof while the plug is worn. The meatal plate 206 further has a tab 208 and a a groove 207 within its upper portion, which acts as a retaining means, to be described in further detail below. The meatal plate 206 also has an opening 211 therein, lying within the plane of the opening of the outer tube 202, through which an inner tube 212 passes.
WO94/26215 2 1 6 3 1 ~ I PCT~S94/05536 ;, .. I~ ,~
Referring again to Figure 3A, inner tube 212 fits within the outer tube 202, and is preferably longer than the outer tube 202.
The inner tube 212, has a plurality of cuts 213 defining a - plurality of elongated segments 215 therein. The inner tube 212 is made from a biocompatible material having a property of com-pressibility. The inner tube 212 further has a flange 218 at its distal end which aids in securing the inner tube 212 within the outer tube 202 after deployment. The inner tube 212 has a cord 216 attached to its bottom end, which aids in the removal of the plug 210.
The user inserts the plug 210 while it is in the configura-tion shown in Figure 3A. Once the plug has been inserted and the meatal plate 206 abuts the meatus urinarius, the plug 210 may be deployed by the wearer, whereupon it achieves the expanded con-figuration set forth in Figure 3B. To deploy, the wearer pushes the inner tube 212 into the outer tube 202, thus causing the proximal end of the inner tube 212 to abut the end cap 214 of the outer tube 202. The wearer continues to push in the vertical direction until the elongated segments 215 of the inner tube 212 expand in the horizontal direction. The elongated segments 215, thus flare-out, until each elongated segment 215 pops through one of the elongated apertures 201 in the outer tube. Upon popping through the apertures 201, the elongated segments 215 cause the balloon 204 to expand. The wearer continues to push until the flange 218 of the inner tube 212 is received in the groove 207 of the outer tube 202, whereupon the two members form a snap-fit thereby locking the elongated segments 215 in a flared configura-tion.
The balloon 204, having expanded with the flaring of the elongated segments 215, thus forms a seal with the urethral, bladder neck or bladder wall, and thus functions to retain the device and block the flow of urine. When the wearer wishes to remove the plug 210, a simple tug on the cord 216 breaks the snap fit connection between the flange 218 and the groove 207, thereby releasing the flange. This releasing action will cause the elon-gated segments 215 of the inner tube 212 to retract as the distal end of the inner tube 212 is pulled down and away from abutment WO94/26215 ~ PCT~S94/05536 2.~ 63~3~ 12 with the end cap 214. Thus, the elongated segments 215 will again lie flush within the outer tube, as shown in Figure 3A, making removal of the plug a comfortable and easy procedure.
The urethral plug assemblies of Figures 4A, 4B, are com-prised of a temperature sensitive compound, more particularly a plastic polymer compound, even more particularly, a polyurethane-based polymer compound. The compound isise~ected for its expan-sion properties when subjected to temperatures of up to about and including 37 C, which temperatures encompass the range of temperature of a mAmmAlian body, more particularly, a human body.
The compound further exhibits properties of shape memory.
The plug of this embodiment is formed from a mold having a hollow center. The shape memory polymer material is blow molded into the maximum expanded shape desired for the plug. The plug in this maximum expanded shape is then drawn through a tubular shaped die heated beyond the transition temperature of the shape memory polymer material, thereby reducing the diameter of the to form a smaller diameter tubular shape, hereinafter referred to as the 'pre-insertion'. Immediately after withdrawing the plug from the die, it is cooled to a temperature below the transition temperature of the shape memory polymer material to maintain its pre-insertio~ shape. This process produces a plug suitable for insertion into a subject's urethra.
The plug in its pre-insertion shape is now ready for packag-ing. Packaging means includes encasing the plug in a suitable plastic molded tray designed to maintain the pre-insertion diameter during shipping, as h~n~l;ng and temperature fluctua-tions above the transition temperature of the shape memory polymer material may follow. Encasing the plug in a gelatin material will also maintain the pre-insertion diameter while the plug is in storage or transit. For those plugs packaged in gelatin, the gelatin simply dissolves when exposed to moisture in the body when inserted by the subject.
Upon insertion of the plug into the urethra of a mAmm~l, the plug is exposed to a temperature gradient which triggers automatic expansion of the device. R~memhering the original diameter inherent to its mold shape, the plug begins to expand ~ WO94/26215 2 1 6 3 1 3 1 i~ i; PCT~Sg4/05536 from its pre-insertion shape to its mold shape. As it expands toward this end, the plug conforms to the shape and size of the urethra, especially upstream of the sphincter toward the bladder neck. The plug continues to expand diametrically as it continues to realize its mold shape, with the outer limits of expansion defined by the walls Qf the urethra. Under no circumstances, however, can the plug expand beyond the ~imen.~ions of its original mold shape. The shape memory polymer comprising the plug is only capable of expanding and conforming to the environ-ment into which it is placed; it is incapable of exerting a resistive force by itself.
There is no need to custom make the plug for each in-dividual; the subject's urethra is simply measured by a physician to ensure that the proper length and size plug is used. The plug may be manufactured in several lengths and sizes in order to ac-commodate males and females, adults and children. In its active and operational state, after having been properly sized and used, the plug forms a secure seal with the urethral, bladder neck or bladder wall. The flow of urine through the urethra is thus blocked.
Figure 4A shows the urethral plug 410 in its contracted con-figuration. Tube 420 is a hollow, thin-walled cylindrical tube which is sized to be easily inserted through the orifice of the urethra. The tube 420 is made from a biocompatible material having characteristics of expansion and compressibility. At the distal end of the tube 420 is a meatal plate 406. The meatal plate 406 is a flanged-type member which is adapted to anchor the urethral plug at the meatus urinarius. To carry out this func-tion of anchoring, the meatal plate 406 is of a thickness suffi-cient to withstand bodily compression during wear, preferably on the order of l millimeter or greater. The meatal plate 406 will prevent the plug from passing through the orifice of the urethra and into the proximal urethra, bladder neck or bladder.
The tube 420 is preferably formed of a biocompatible ther-moplastic material. In a preferred embodiment, the tube 420 is made of a known polyurethane-based polymer which provides the plug with shape memory. The unique characteristic of the plas-WO94/26215 ~ ~3 l 3 ~ PCT~S94/05536 tic polymer is its thermally triggered shape memory, which allowsthe tube 420 constructed of the shape memory polymer to be in-serted into the urethra in a relatively compressed and elongated state, and regain a useful shape at a selected temperature, such as human body temperature. The two interchangeable shapes are possible because the shape memory polymer-has "elastic memory", that is, a large reversible change in el~stic modulus across the glass transition temperature (Tg). Thus, the shape memory polymer offers the unique characteristic of changing from a glassy, more rigid condition to a softer, rubbery condition across the Tg temperature. Such a large change in elastic modulus around the Tg temperature allows for significant deforma-tion in response to temperature changes. An increase in tempera-ture allows the shape memory polymer to become more flexible and, therefore, easily deformable into a new shape. The glass transi-tion of a polymer, such as the shape memory polymer of the preferred embodiment, is depicted below. The diagram demonstrates a first transition from a glassy state to a rubbery state as the temperature increases, and a second transition from a rubbery state to a fluid state as the temperature is allowed to further increase. It is the first transition from the glassy state to the rubbery state that is exploited in the present invention.
Any compound with thermally-triggered shape memory and having a glass transition temperature approximately that of mam-malian body temperature can be used in the device of the present invention. A preferred compound is the polyurethane-based shape memory polymer as described above, developed by Mitsubishi Heavy Industries, Ltd. and available from Memry Technologies in Brook-field, CT.
Accordingly, when the urethral plug shown in Figure 4A is subjected to a transition temperature, the relatively rigid plug changes to a second condition in which it is flexible and easily deformable. The plug is now pliable and, remembering its " mold shape plug", able to expand significantly in diameter to conform to the shape of the wearer's urethra. A tight seal with the urethra, bladder neck or bladder wall is formed and the plug is WO94/~6~15 2 1 6 3 ~ ~ 1 PCT~594/05536 retained in the wearer's urethra to block the flow of urine.
In accordance with the above discussion, the user inserts the urethral plug of the present invention into the urethra while ~ it is in the configuration of Figure 4A. Once the plug has been inserted into the urethra and the meatal plate 406 abuts the meatus urinarius, the plug is exposed to the heightened tempera-ture of the human body. The temperature increase causes the shape memory polymer comprising the tube 420 to automatically ex-pand outwardly and achieve a protrusion 422 to conform to the size and shape of the wearer's urethra. The shape memory polymer is able to freely adapt and conform to its environment - here, the urethra - because, as already discussed, it is only capable of expanding and conforming to the environment into which it is placed; it is incapable of exerting a resistive force by itself.
This important characteristic of the shape memory polymer prevents displacement of the urethra, bladder neck or bladder by the shape memory polymer material.
The plug is now in its expanded configuration 422 as set forth in Figure 4B. As urine accumulates in the bladder, pres-sure from the accumulating urine builds until the bladder is suf-ficiently full to exert a downward force on the urine in the bladder neck and urethra. The downward force in turn bears down on the proximal portion of the expanded member of the plug, furthering the diametrical expansion of the proximal portion of the member. The expansion of the plug, in its expanded form, provides a tight seal with the wall of the urethra, bladder neck or bladder to retain the plug in the wearer's body. When the wearer wishes to remove the plug to void, a continuous tug on tab 408 of the meatal plate 406 will cause the rubbery, diametrically expanded member to elongate. The tube 420 is then returned to a smaller diameter and is simply withdrawn from the body. Other means for removal of the plug are contemplated, such as but not limited to, a pulling means, such as a cord, whereby the plug is simply removed by pulling on a cord attached to the plug. The ease with which the shape memory polymer plug allows removal prevents discomfort potentially associated with plug removal.
Figure 5A shows a second embodiment of the automatically ex-O94/26215 2 1 G 3 1 3 l PCT~S94/05536t pandable urethral plug 510 of the present invention in its con-tracted configuration. Similar to the first embodiment discussed above, tube 502 comprises a hollow, thin-walled cylindrical shaft which is sized to be easily inserted through the orifice of the urethra. In an alternative embodiment, the tube 502 may comprise a solid cylindrical shaft. The tube'`'502 may be made of any inert material suitable for insertion into a m~mm~lian body.
The tube 502 is made from a biocompatible' material, preferably from a biocompatible thermoplastic elastomer, more preferably from a biocompatible polyurethane-based polymer. The most preferred tube is injection molded Kraton G, a non-toxic, biocom-patible thermoplastic elastomer. Other suitable materials in-clude polyethylene and nylon polymers, and other copolymers similar thereto.
At the proximal end 504 of tube 502, there is an expandable, deformable member 507 which, upon insertion into a m~mm~lian body, is exposed to normal bodily conditions. Exposure to the normal bodily conditions in turn causes the member 507 to expand and achieve its expanded configuration, as shown in Figure 5B.
The member 507 may be sponge or any suitable absorbent hydrophillic material. The expandable, deformable member 507 may be attached to the tube 502 by an adhesive, a collar, thermal bonding, or any attaching means suitable for the materials selected for the member 507. The bodily conditions which affect the member 507 are temperature (as in the shape memory material device); moisture; pH gradations; and/or other such conditions that act on and expand the member 507.
At the distal end 505 of the tube 502 is a meatal plate 506 which, as in the aforementioned embodiment, is a flanged-type mem.~ber with a thickness sufficient to prevent compression by the urethra during insertion and wear, preferably on the order of 1 millimeter or greater. Additionally on the meatal plate is a tab 508 for ease of removal. Tab 508 is instructive only and can be substituted by other removal means such as, but not limited to, a cord 510 attached to the inside of the tube 502 and extending downwardly through the opening 509 in the meatal plate. Any other such adaptation sufficient to allow removal of the device ~ . ~ r .~
S ~r~~ ~
WO94/2621~ 2 1 6 ~ 1 3 1 PCT~S94/05536 by a simple, continuous pulling by the subject, without tools or undue force, is e~ually contemplated.
The expandable, deformable member 507 has a pre-insertion shape which is sufficiently sized to allow easy insertion into the urethra of a m~mm~lian body, more particularly, a human body.
once inserted, natural conditions in the body cause expansion, preferably diametrical~expansion, of the member 507. In one em-bodiment, the member would be a sponge secured to the tube 502 by any of, but not limited to, the aforementioned attaching means. Upon insertion of the plug into the body, the sponge is exposed to and absorbs moisture naturally present in the body and expands diametrically, thereby forming a secure seal with the urethral, bladder neck or bladder wall of the body. As in the urethral plug comprised of the shape memory polymer material, the urethral plug of this embodiment also expands diametrically until it meets with resistance from the walls of the urethra, bladder neck or bladder. The member 507 maintains its expanded state until acted upon by the wearer, for instance, when voiding is desired. The diametrically expanded member is sufficiently soft and deformable so as to respond to the downward pressure exerted by the wearer's pulling on the tab 508 or other pulling means.
A continuous tug on tab S08 of the meatal plate 506, or on cord 510, will cause the expanded member 507 to elongate, as it meets tissue resistance. The plug is then returned to a smaller diameter and is simply withdrawn from the body.
Figure 7A shows a cross sectional view of the urethral plug along line A-A of the preferred embodiments set forth above.
Tube 300 represents the diameter of outer tubes 2, 202 of Figures lA and 3B, and as applicable to the embodiments of Figures 2A, 4A, 5A the diameter of the tubes 102, 420, and 502, respectively.
Figure 7B shows an alternate embodiment, along line A-A, of the above mentioned tubes, in cross section. As shown, the diameter of tube 700 is not constant but variant as shown by the curved indentations 702 on the periphery. The indentations 702 provide enhanced surface area by which the plug may more readily adapt to the urethral wall. Such enhanced sealing ability of the plug, means a better fit for the wearer.
2l63131 WO94/26215 l ,~f I ~., PCT~S94/05536 The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the ac-companying drawings and pointed out in the claims. It will be understood that the particular devices embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.
migration of the device into the bladder. In United States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in the bladder. The patient increases his bladder pressure by means of a valsalva maneuver, and holds this pressure while the valve ; activates. Urine may then pass through the valve with the valve later returning to its closed position. This device is very complicated, expensive, difficult to manufacture and uncomfortable. Another physician-inserted device is disclosed in United States Patent No. 3,797,478. This device has an expandable collar which is inflated after insertion, by an injection of fluid therein. When it is desired to remove the device, the inflated collar is ruptured or serrated, thus expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection associated with the release of injection fluid upon removal.
Similarly, United States Patent No. 3,841,304 discloses a plug which is inserted by a physician into the urethra and subse~uently inflated to block the flow of urine. This device may be left in the body for extended periods. After insertion, the device merely requires repositioning in the urethra to permit bladder evacuation. Such a device leaves the wearer susceptible to infection, as bacteria may be introduced into the urethra during repositioning, or during indwelling time. Also, serious complications can occur upon removal, when a separate wire must be inserted therein. These devices being indwelling, are often cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection.
Also known in the art are devices capable of being inserted by the wearer into the urethra. Such devices are removed for voiding, and then reintroduced into the urethra upon completion of bladder evacuation. An example of such a device is the solid-type urethral plug, described by Neilsen, Kurt K. et al., in "The Urethral Plug: A New Treatment Modality for Genuine Uri-nary Stress Incontinence in Women" J. Urology, vol. 44, p. llOO
(l990). This device consists of one or two solid spheres located along a soft shaft, and a thin, soft plate located at the end of WO94/26215 ~. ~ PCT~S94105536 21 63~ 31 4 ~
the shaft. One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of the sphincter. In the two sphere embodiment, the second sphere is located with its midpoint at the bladder neck, and is used to assist in reducing urinary flow and pressure transmission to the urethra so that the sphincter can operate. When the patient wants to evacuate the bladder, the plug is removed, evacuation occurs, and a fresh plug is inserted. One problem associated with this device is that the patient must have three urethral closure pressure profiles performed as well as other exAmln~tions, before the device is made for the wearer.
Additional problems associated with this device include placement difficulties, lack of sealing capabilities associated therewith, inade~uate retention thereby allowing expelling and inade~uate anchoring by the plate at the meatus. In addition to such problems of inadequate placement, sealing, and retention, is the discomfort associated with insertion and removal, due to the size profile and rigidity of the spheres. The spheres of this device maintain a constant diameter during insertion, and removal.
Another "remove-to-void" device is disclosed in United States Patent No. 5,090,424, which comprises a conformable urethral plug. The body of the plug forms a cavity which is in fluid com-munication with another cavity via a check-valve. Thus, fluid may be pumped into the cavity within the urethra to provide a custom fit. This device, like many others relying on liquids or gels for expansion, relies heavily on a fluid-tight valve in or-der to maintain retention. Should valve failure occur, evacua-tion would immediately follow. There is also a chance of fluid leakage into the body of the wearer should rupture of the plug occur.
In view of the above problems associated with the prior art, an easily usable, expandable plug device of a non-fluid construc-tion, which is mechanically actuated, would be desirable to those afflicted with urinary incontinence.
OBJECTS OF THE INVENTION
One object of the invention is to provide a urethral plug wo94l26~ls 2 ~ 6 3 1 3 I rcT~ss4lo5s36 which is easily manipulated by the wearer.
Another object of the invention is to improve the degree of comfort associated with insertion and removal of a urethral plug.
- A further object of the invention is to enhance the sealing ability of a urethral plug with the urethra, bladder neck or ; bladder wall.
Another object of the invention is to stabilize the place-ment of a urethral plug at the urethral meatus, such that migra-tion into the bladder will not occur.
Still another object of the invention is to reduce the risk of infection to the wearer of a urethral plug .
Still another object of the invention is to provide a method of using a manually deployable urethral plug by patients suffer-ing from urinary incontinence.
It is yet another object of the present invention to provide a method of using a removable-to-void urethral plug which expands automatically without user intervention for retention in the body and to block the flow of urine in the urethra.
These and other objects of the invention are carried out by an expandable urethral plug having a contracted diameter for in-sertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder. In a first embodiment, the plug comprises a cooperating housing and inner member lying in coaxial engagement. A larger diameter is achieved by mechanical deployment of the inner member, resulting in the changing of the shape of the housing, or in another embodiment, the changing of the shape of the inner member. In an alternative embodiment the urethral plug comprises a member comprised of material which un-dergoes automatic expansion when exposed to temperature or li-~uid. The urethral plug assumes a non-expanded first condition when exposed to a temperature approximately less than that of a m~mm~l ian body, and assumes an expanded second condition when ex-posed to a transition temperature of approximately the body tem-perature of a m~mm~ 1 . In yet another embodiment, the expanded second condition is achieved when the urethral plug is exposed to natural bodily conditions such as, but not limited to, body WO94/26215 , f-~ PCT~S94/05~36 21 63l 31 moisture.
In each embodiment, the expansion of the plug causes a bal-loon to expand, which seals the plug to the urethral, bladder neck and bladder wall. The plug further has a meatal plate for anchoring the plug in the urethra, which preven:ts migration of both the plug and the cord into the bladder.-~ Removal of the plug for bladder evacuation, may be easily accomplished by pull-ing a cord. In accordance with a further feature of the inven-tion, there is provided a method for controlling incontinence in humans.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure lA shows a first embodiment of the urethral plug which has an expansible outer tube, in its contracted configura-tion.
Figure lB shows the first embodiment of the urethral plug in its expanded configuration.
Figure 2A shows a second embodiment of the urethral plug which has a braided mesh, in its contracted configuration.
Figure 2B shows the second embodiment of the urethral plug in its expanded configuration.
Figure 3A shows a third embodiment of the urethral plug in its contracted configuration.
Figure 3B shows the third embodiment of the urethral plug in its expanded configuration.
Figure 4A shows a fourth embodiment of the urethral plug, which is thermally expandable, in its contracted configuration.
Figure 4B shows a fourth embodiment of the urethral plug, which is thermally expandable, in its expanded configuration.
Figure 5A shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its contracted configuration.
Figure 5B shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its expanded configuration.
Figure 6 shows an end view of the meatal plate of the urethral plug of each of the above embodiments.
wo94l262ls 2 1 6 3 1 3 1 -~ PCT~S94/05536 Figure 7A shows an cross sectional view of the urethral plug.
Figure 7B shows a cross sectional view of an alternate em-bodiment of the urethral plug.
DETAILED DESCRIPTION OF THE INVENTION
Figure lA shows the urethral plug of the first embodiment 10, in its contracted configuration. The plug housing comprises a hollow, cylindrical tube 2 which is sized to be easily inserted through the orifice of the urethra. The tube 2 is made from a biocompatible material having characteristics ofcompressibility.
Attached on the periphery thereof either by thermal bonding, laminating or other means, is a sealing membrane, or balloon, 4 which is adapted to rest against the outer tube 2. At the distal end of the tube 2 is a meatal plate 6. The meatal plate 6 is adapted to anchor the urethral plug 10 at the meatus urinarius.
To carry out this function of anchoring, the meatal plate 6 is of a thickness sufficient to withstand bodily compression during wear, preferably on the order of 1 millimeter or greater. The meatal plate 6 prevents the plug 10 from passing through the orifice in the urethra ultimately leading into the bladder neck or bladder.
Figure 6 shows an end view of the meatal plate 6, which is the same as the meatal plates to be shown in future embodiments.
A portion of the meatal plate 6 is extended so as to form a tab 8 which may be grasped by the wearer for ease of removal. The meatal plate may further aid in maintaining the plug's expanded configuration during wear, by providing means for securing, such as a ball retention socket (not shown). The meatal plate 6 also has an opening 11 therein, lying within the plane of the opening of the outer tube 2.
Referring again to Figure lA, enclosed within the tube 2 is a support rod 12, which may be a hollow or a solid member. The support rod 12 has a bulb 14 at one end thereof, abutting the proximal end of the tube 2. The bulb 14 functions to hold the support rod 12 within the tube 2. The support rod 12 has a cord 16 attached at its end opposite the bulb 14, which extends WO94/26215 - - ~; PCT~S94/05536 2 1 6 3 1 3 1 ~
through the tube 2 and beyond the meatal plate 6, thus ensuring that a wearer will always be able to reach the cord 16. On the cord 16 there is preferably formed a knot 18. Although the knot 18 has been used, the attachment of any member having a diameter greater than ball retention socket 7 would suffice. The support rod 12 is preferably stainless steel, the o~ter tube 2 is preferably formed of a biocompatible thermoplastic material and the balloon 4 is preferably a biocompatible~thermoplastic elas-tomer, such as that sold under the trademark KRATON. However, any biocompatible material may be used for each of the aforemen-tioned elements, as the invention is not to be limited to those named above. Lines A-A' represents the cross sectional view of the tube 2, which will be discussed further with reference to Figures 7A and 7B.
A user inserts the plug 10 while it is in the configura-tion shown in Figure lA. Once the plug 10 has been inserted and the meatal plate 6 abuts the meatus urinarius, the plug 10 may be deployed by the wearer, upon which it achieves an expanded configuration, as set forth in Figure lB. To deploy, the wearer pulls on the cord 16 depending from the support rod 12. By pull-ing, a downward force is exerted on the cord 16 in the vertical direction, forcing the support rod 12 to slide downwardly in the tube 2 and exert a compressive force against the proximal end of the outer tube 2. The tube 2 thus expands outwardly in the horizontal direction, causing the balloon 4 to expand until the balloon forms a seal with the wall of the urethra, bladder neck or bladder. The wearer then secures the cord by sliding it through a slit (not shown) in the ball retention socket 7 located on the meatal plate 6. This causes the knot 18 to act as a stop, as the knot 18 rests within the socket 7, thereby preventing the tube 2 from returning to its contracted state (Figure lA).
The plug 10 in an expanded form as shown in Figure lB, functions to retain and block the flow of urine. When the wearer wishes to remove the plug, a simple tug on the cord 16 in a direction away from the socket 7 will cause the knot 18 to be released therefrom, thus causing the tube 2 to retract to its contracted state of Figure lA. The tube 2 thereby returns to its WO94/26215 2 ¦ 6 3 1 ~ ~PCT~S94/05536 original diameter prior to insertion, making plug removal a comfortable task. Thus, the tube 2 and balloon 4 cooperatively provide an expandable housing and the plug includes means for mechanically expanding the housing and selectively returning the housing to its non-expanded condition.
Figure 2A shows a second embodiment of the urethral plug 110 in its contracted configuration. Tube 102 is formed by a flexible braided mesh 103. Attached on the periphery thereof either by thermal bonding, laminating or other means, is a seal-ing membrane, or balloon, 104 which is adapted to rest against the tube 102. Enclosed within the tube 102 is a support rod 112, which may be a hollow or a solid member. The support rod has a bulb 114 at one end thereof, fixed to the proximal end of the tube 102. The bulb 114 functions to secure the support rod 112 within the tube 102. The support rod 112 has a cord 116 attached at its end opposite the bulb 114, which extends through the tube 102 and beyond the meatal plate 106, thus ensuring that a wearer will always be able to reach the cord 116. The cord 116 preferably has formed therein a knot 118. Although a knot 118 has been used, the att~chment of any member having a diameter greater than ball retention socket 107 would suffice. The sup-port rod 112 is preferably stainless s,teel, the outer tube 102 is preferably formed of a biocompatible thermoplastic material and the balloon 104 is preferably a biocompatible thermoplastic elastomer, such as that sold under the tr~em~rk KRATON.
However, any biocompatible material may be used for each of the aforementioned elements, as the invention is not to be limited to those named above. Lines A-A' represent the cross sectional view of the tube 102, which will be discussed further with reference to Figures 7A and 7B.
The user inserts the plug 110 while it is in the configuration shown in Figure 2A. Once the plug has been inserted and the meatal plate 106 abuts the orifice of the urethra, the plug is deployed by the wearer, upon which it achieves the expanded configuration as set forth in Figure 2B.
To deploy, the wearer pulls down on the cord 116, in a direction opposite the direction of initial insertion of the device. Thus, WO94126215 2 t 6 31 3 l : ~ PCT~S94/05~36 a compressive force is exerted in the vertical direction by the cord 116 on the bulb 114, which is transmitted from the bulb 114 to the tube 102. This force causes the braided mesh 103 to expand outwardly in the horizontal direction. The expansion of the braided mesh forms an oval projection, which projection causes the balloon 104 to expand therewith. The wearer then secures the cord 116 by sliding it through the slit (not shown) in the ball retention socket 107 in the meatal plate 106. This causes the knot 118 to act as a stop, as the knot is brought to rest within the socket 107, thereby preventing the braided mesh 103 from returning to its contracted state as shown in Figure 2A). The balloon thus retains its seal with the urethral, bladder neck or bladder wall and functions to block the flow of urine.
When the wearer wishes to remove the plug , a simple tug on the cord 116 in a direction away from the socket 107 will cause the knot 118 to be released therefrom, thus causing the braided mesh 103 to retract. The tube 102 thereby returns to its original diameter prior to insertion, making plug removal a com-fortable task.
Figure 3A shows the plug 210 of the third embodiment of the present invention in its contracted state. An outer tube 202 has a plurality of elongated apertures 201 formed therein. Line A-A' represents the cross sectional view of the outer tube 202 which will be discussed further with reference to Figures 7A and 7B.
Attached to the periphery of the outer tube 202, is a sealing membrane, or balloon 204 which is its pre-insertion configuration (Figure 3A), is adapted to rest against the outer tube 202. At the proximal end of the outer tube 202 is an end cap 214. At the distal end of the outer tube 202 is a meatal plate 206 which has a thickness sufficient to prevent compression thereof while the plug is worn. The meatal plate 206 further has a tab 208 and a a groove 207 within its upper portion, which acts as a retaining means, to be described in further detail below. The meatal plate 206 also has an opening 211 therein, lying within the plane of the opening of the outer tube 202, through which an inner tube 212 passes.
WO94/26215 2 1 6 3 1 ~ I PCT~S94/05536 ;, .. I~ ,~
Referring again to Figure 3A, inner tube 212 fits within the outer tube 202, and is preferably longer than the outer tube 202.
The inner tube 212, has a plurality of cuts 213 defining a - plurality of elongated segments 215 therein. The inner tube 212 is made from a biocompatible material having a property of com-pressibility. The inner tube 212 further has a flange 218 at its distal end which aids in securing the inner tube 212 within the outer tube 202 after deployment. The inner tube 212 has a cord 216 attached to its bottom end, which aids in the removal of the plug 210.
The user inserts the plug 210 while it is in the configura-tion shown in Figure 3A. Once the plug has been inserted and the meatal plate 206 abuts the meatus urinarius, the plug 210 may be deployed by the wearer, whereupon it achieves the expanded con-figuration set forth in Figure 3B. To deploy, the wearer pushes the inner tube 212 into the outer tube 202, thus causing the proximal end of the inner tube 212 to abut the end cap 214 of the outer tube 202. The wearer continues to push in the vertical direction until the elongated segments 215 of the inner tube 212 expand in the horizontal direction. The elongated segments 215, thus flare-out, until each elongated segment 215 pops through one of the elongated apertures 201 in the outer tube. Upon popping through the apertures 201, the elongated segments 215 cause the balloon 204 to expand. The wearer continues to push until the flange 218 of the inner tube 212 is received in the groove 207 of the outer tube 202, whereupon the two members form a snap-fit thereby locking the elongated segments 215 in a flared configura-tion.
The balloon 204, having expanded with the flaring of the elongated segments 215, thus forms a seal with the urethral, bladder neck or bladder wall, and thus functions to retain the device and block the flow of urine. When the wearer wishes to remove the plug 210, a simple tug on the cord 216 breaks the snap fit connection between the flange 218 and the groove 207, thereby releasing the flange. This releasing action will cause the elon-gated segments 215 of the inner tube 212 to retract as the distal end of the inner tube 212 is pulled down and away from abutment WO94/26215 ~ PCT~S94/05536 2.~ 63~3~ 12 with the end cap 214. Thus, the elongated segments 215 will again lie flush within the outer tube, as shown in Figure 3A, making removal of the plug a comfortable and easy procedure.
The urethral plug assemblies of Figures 4A, 4B, are com-prised of a temperature sensitive compound, more particularly a plastic polymer compound, even more particularly, a polyurethane-based polymer compound. The compound isise~ected for its expan-sion properties when subjected to temperatures of up to about and including 37 C, which temperatures encompass the range of temperature of a mAmmAlian body, more particularly, a human body.
The compound further exhibits properties of shape memory.
The plug of this embodiment is formed from a mold having a hollow center. The shape memory polymer material is blow molded into the maximum expanded shape desired for the plug. The plug in this maximum expanded shape is then drawn through a tubular shaped die heated beyond the transition temperature of the shape memory polymer material, thereby reducing the diameter of the to form a smaller diameter tubular shape, hereinafter referred to as the 'pre-insertion'. Immediately after withdrawing the plug from the die, it is cooled to a temperature below the transition temperature of the shape memory polymer material to maintain its pre-insertio~ shape. This process produces a plug suitable for insertion into a subject's urethra.
The plug in its pre-insertion shape is now ready for packag-ing. Packaging means includes encasing the plug in a suitable plastic molded tray designed to maintain the pre-insertion diameter during shipping, as h~n~l;ng and temperature fluctua-tions above the transition temperature of the shape memory polymer material may follow. Encasing the plug in a gelatin material will also maintain the pre-insertion diameter while the plug is in storage or transit. For those plugs packaged in gelatin, the gelatin simply dissolves when exposed to moisture in the body when inserted by the subject.
Upon insertion of the plug into the urethra of a mAmm~l, the plug is exposed to a temperature gradient which triggers automatic expansion of the device. R~memhering the original diameter inherent to its mold shape, the plug begins to expand ~ WO94/26215 2 1 6 3 1 3 1 i~ i; PCT~Sg4/05536 from its pre-insertion shape to its mold shape. As it expands toward this end, the plug conforms to the shape and size of the urethra, especially upstream of the sphincter toward the bladder neck. The plug continues to expand diametrically as it continues to realize its mold shape, with the outer limits of expansion defined by the walls Qf the urethra. Under no circumstances, however, can the plug expand beyond the ~imen.~ions of its original mold shape. The shape memory polymer comprising the plug is only capable of expanding and conforming to the environ-ment into which it is placed; it is incapable of exerting a resistive force by itself.
There is no need to custom make the plug for each in-dividual; the subject's urethra is simply measured by a physician to ensure that the proper length and size plug is used. The plug may be manufactured in several lengths and sizes in order to ac-commodate males and females, adults and children. In its active and operational state, after having been properly sized and used, the plug forms a secure seal with the urethral, bladder neck or bladder wall. The flow of urine through the urethra is thus blocked.
Figure 4A shows the urethral plug 410 in its contracted con-figuration. Tube 420 is a hollow, thin-walled cylindrical tube which is sized to be easily inserted through the orifice of the urethra. The tube 420 is made from a biocompatible material having characteristics of expansion and compressibility. At the distal end of the tube 420 is a meatal plate 406. The meatal plate 406 is a flanged-type member which is adapted to anchor the urethral plug at the meatus urinarius. To carry out this func-tion of anchoring, the meatal plate 406 is of a thickness suffi-cient to withstand bodily compression during wear, preferably on the order of l millimeter or greater. The meatal plate 406 will prevent the plug from passing through the orifice of the urethra and into the proximal urethra, bladder neck or bladder.
The tube 420 is preferably formed of a biocompatible ther-moplastic material. In a preferred embodiment, the tube 420 is made of a known polyurethane-based polymer which provides the plug with shape memory. The unique characteristic of the plas-WO94/26215 ~ ~3 l 3 ~ PCT~S94/05536 tic polymer is its thermally triggered shape memory, which allowsthe tube 420 constructed of the shape memory polymer to be in-serted into the urethra in a relatively compressed and elongated state, and regain a useful shape at a selected temperature, such as human body temperature. The two interchangeable shapes are possible because the shape memory polymer-has "elastic memory", that is, a large reversible change in el~stic modulus across the glass transition temperature (Tg). Thus, the shape memory polymer offers the unique characteristic of changing from a glassy, more rigid condition to a softer, rubbery condition across the Tg temperature. Such a large change in elastic modulus around the Tg temperature allows for significant deforma-tion in response to temperature changes. An increase in tempera-ture allows the shape memory polymer to become more flexible and, therefore, easily deformable into a new shape. The glass transi-tion of a polymer, such as the shape memory polymer of the preferred embodiment, is depicted below. The diagram demonstrates a first transition from a glassy state to a rubbery state as the temperature increases, and a second transition from a rubbery state to a fluid state as the temperature is allowed to further increase. It is the first transition from the glassy state to the rubbery state that is exploited in the present invention.
Any compound with thermally-triggered shape memory and having a glass transition temperature approximately that of mam-malian body temperature can be used in the device of the present invention. A preferred compound is the polyurethane-based shape memory polymer as described above, developed by Mitsubishi Heavy Industries, Ltd. and available from Memry Technologies in Brook-field, CT.
Accordingly, when the urethral plug shown in Figure 4A is subjected to a transition temperature, the relatively rigid plug changes to a second condition in which it is flexible and easily deformable. The plug is now pliable and, remembering its " mold shape plug", able to expand significantly in diameter to conform to the shape of the wearer's urethra. A tight seal with the urethra, bladder neck or bladder wall is formed and the plug is WO94/~6~15 2 1 6 3 ~ ~ 1 PCT~594/05536 retained in the wearer's urethra to block the flow of urine.
In accordance with the above discussion, the user inserts the urethral plug of the present invention into the urethra while ~ it is in the configuration of Figure 4A. Once the plug has been inserted into the urethra and the meatal plate 406 abuts the meatus urinarius, the plug is exposed to the heightened tempera-ture of the human body. The temperature increase causes the shape memory polymer comprising the tube 420 to automatically ex-pand outwardly and achieve a protrusion 422 to conform to the size and shape of the wearer's urethra. The shape memory polymer is able to freely adapt and conform to its environment - here, the urethra - because, as already discussed, it is only capable of expanding and conforming to the environment into which it is placed; it is incapable of exerting a resistive force by itself.
This important characteristic of the shape memory polymer prevents displacement of the urethra, bladder neck or bladder by the shape memory polymer material.
The plug is now in its expanded configuration 422 as set forth in Figure 4B. As urine accumulates in the bladder, pres-sure from the accumulating urine builds until the bladder is suf-ficiently full to exert a downward force on the urine in the bladder neck and urethra. The downward force in turn bears down on the proximal portion of the expanded member of the plug, furthering the diametrical expansion of the proximal portion of the member. The expansion of the plug, in its expanded form, provides a tight seal with the wall of the urethra, bladder neck or bladder to retain the plug in the wearer's body. When the wearer wishes to remove the plug to void, a continuous tug on tab 408 of the meatal plate 406 will cause the rubbery, diametrically expanded member to elongate. The tube 420 is then returned to a smaller diameter and is simply withdrawn from the body. Other means for removal of the plug are contemplated, such as but not limited to, a pulling means, such as a cord, whereby the plug is simply removed by pulling on a cord attached to the plug. The ease with which the shape memory polymer plug allows removal prevents discomfort potentially associated with plug removal.
Figure 5A shows a second embodiment of the automatically ex-O94/26215 2 1 G 3 1 3 l PCT~S94/05536t pandable urethral plug 510 of the present invention in its con-tracted configuration. Similar to the first embodiment discussed above, tube 502 comprises a hollow, thin-walled cylindrical shaft which is sized to be easily inserted through the orifice of the urethra. In an alternative embodiment, the tube 502 may comprise a solid cylindrical shaft. The tube'`'502 may be made of any inert material suitable for insertion into a m~mm~lian body.
The tube 502 is made from a biocompatible' material, preferably from a biocompatible thermoplastic elastomer, more preferably from a biocompatible polyurethane-based polymer. The most preferred tube is injection molded Kraton G, a non-toxic, biocom-patible thermoplastic elastomer. Other suitable materials in-clude polyethylene and nylon polymers, and other copolymers similar thereto.
At the proximal end 504 of tube 502, there is an expandable, deformable member 507 which, upon insertion into a m~mm~lian body, is exposed to normal bodily conditions. Exposure to the normal bodily conditions in turn causes the member 507 to expand and achieve its expanded configuration, as shown in Figure 5B.
The member 507 may be sponge or any suitable absorbent hydrophillic material. The expandable, deformable member 507 may be attached to the tube 502 by an adhesive, a collar, thermal bonding, or any attaching means suitable for the materials selected for the member 507. The bodily conditions which affect the member 507 are temperature (as in the shape memory material device); moisture; pH gradations; and/or other such conditions that act on and expand the member 507.
At the distal end 505 of the tube 502 is a meatal plate 506 which, as in the aforementioned embodiment, is a flanged-type mem.~ber with a thickness sufficient to prevent compression by the urethra during insertion and wear, preferably on the order of 1 millimeter or greater. Additionally on the meatal plate is a tab 508 for ease of removal. Tab 508 is instructive only and can be substituted by other removal means such as, but not limited to, a cord 510 attached to the inside of the tube 502 and extending downwardly through the opening 509 in the meatal plate. Any other such adaptation sufficient to allow removal of the device ~ . ~ r .~
S ~r~~ ~
WO94/2621~ 2 1 6 ~ 1 3 1 PCT~S94/05536 by a simple, continuous pulling by the subject, without tools or undue force, is e~ually contemplated.
The expandable, deformable member 507 has a pre-insertion shape which is sufficiently sized to allow easy insertion into the urethra of a m~mm~lian body, more particularly, a human body.
once inserted, natural conditions in the body cause expansion, preferably diametrical~expansion, of the member 507. In one em-bodiment, the member would be a sponge secured to the tube 502 by any of, but not limited to, the aforementioned attaching means. Upon insertion of the plug into the body, the sponge is exposed to and absorbs moisture naturally present in the body and expands diametrically, thereby forming a secure seal with the urethral, bladder neck or bladder wall of the body. As in the urethral plug comprised of the shape memory polymer material, the urethral plug of this embodiment also expands diametrically until it meets with resistance from the walls of the urethra, bladder neck or bladder. The member 507 maintains its expanded state until acted upon by the wearer, for instance, when voiding is desired. The diametrically expanded member is sufficiently soft and deformable so as to respond to the downward pressure exerted by the wearer's pulling on the tab 508 or other pulling means.
A continuous tug on tab S08 of the meatal plate 506, or on cord 510, will cause the expanded member 507 to elongate, as it meets tissue resistance. The plug is then returned to a smaller diameter and is simply withdrawn from the body.
Figure 7A shows a cross sectional view of the urethral plug along line A-A of the preferred embodiments set forth above.
Tube 300 represents the diameter of outer tubes 2, 202 of Figures lA and 3B, and as applicable to the embodiments of Figures 2A, 4A, 5A the diameter of the tubes 102, 420, and 502, respectively.
Figure 7B shows an alternate embodiment, along line A-A, of the above mentioned tubes, in cross section. As shown, the diameter of tube 700 is not constant but variant as shown by the curved indentations 702 on the periphery. The indentations 702 provide enhanced surface area by which the plug may more readily adapt to the urethral wall. Such enhanced sealing ability of the plug, means a better fit for the wearer.
2l63131 WO94/26215 l ,~f I ~., PCT~S94/05536 The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the ac-companying drawings and pointed out in the claims. It will be understood that the particular devices embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.
Claims (72)
1. A remove-to-void plug assembly for use in the urethra to control urinary incontinence, comprising:
a housing adapted to be inserted into the natural urethral opening of a wearer, a solid element coupled with said housing, which solid element directly impacts on said housing so as to mechanically change the shape of said housing causing at least a portion of said housing to expand outwardly to contact the walls of the urethra, bladder neck or bladder, wherein the mechanical change in shape is effectuated by the wearer after insertion of said housing into the natural urethral opening, said at least a portion of said housing thereby forming a seal with thewalls without the formation of a passageway through said housing to block the flow or urine, and means for reversing the change in shape of said housing to return said housing to its non-expanded state, thereby enabling the wearer to remove said housing from the natural urethral opening and effect bladder evacuation
a housing adapted to be inserted into the natural urethral opening of a wearer, a solid element coupled with said housing, which solid element directly impacts on said housing so as to mechanically change the shape of said housing causing at least a portion of said housing to expand outwardly to contact the walls of the urethra, bladder neck or bladder, wherein the mechanical change in shape is effectuated by the wearer after insertion of said housing into the natural urethral opening, said at least a portion of said housing thereby forming a seal with thewalls without the formation of a passageway through said housing to block the flow or urine, and means for reversing the change in shape of said housing to return said housing to its non-expanded state, thereby enabling the wearer to remove said housing from the natural urethral opening and effect bladder evacuation
2. The plug assembly according to claim 1, said means for reversing the changing of the shape of said housing being integrally connected to the plug assembly.
3. The plug assembly according to claim 1, said housing further comprising an expandable tube having a membrane mounted thereon.
4. The plug assembly according to claim 1, said solid element for changing the shape of said housing comprising a rod positioned within said housing and movable within said housing to cause said changing of the shape of said housing.
5. The plug assembly according to claim 4, said rod having a bulb fixed thereon, whereby movement of said rod causes said bulb to exert a force on said housing causing said changing of the shape of said housing.
6. The plug assembly of claim 4, said means for reversing the changing of the shape of said housing comprising a cord fixed to said rod and extending from said housing, whereby manipulation of said cord causes said movement of said rod in said housing.
7. The plug assembly of claim 6, wherein said assembly further comprises means for securing said housing in an expanded state.
8. The plug assembly of claim 7, wherein said means for securing said housing in said expanded state comprises means for retaining a portion of said cord in anon-movable state.
9. The plug assembly of claim 8, said means for retaining a portion of said cord comprising a socket.
10. The plug assembly of claim 9, said portion of said cord comprising a knot.
11. The plug assembly of claim 1 wherein said housing has a groove therein, and said solid element for mechanically changing the-shape of said housing comprises a rod having a flange disposed thereon, said groove adapted to receivesaid flange so as to maintain the housing in an expanded state.
12. The plug assembly of claim 1, said housing further comprising a meatal plate.
13. The plug assembly of claim 12, said meatal plate further comprising a tab extending from a distal end of said housing, lying substantially normal to said housing.
14. The plug assembly of claim 1, said housing comprising a braided mesh.
15. The plug assembly of claim 1, said housing having curved indentations on the periphery thereof.
16. The plug assembly of claim 1, said housing comprising an outer tube having a plurality of apertures therein.
17. The plug assembly of claim 16, said solid element for mechanically changing the shape of said housing comprising an inner tube having a plurality of elongated segments.
18. A plug assembly adapted to be inserted in the urethra for controlling urinary incontinence, comprising;
a housing having a plurality of apertures therein, a member having a plurality of expandable segments, said member cooperating with said housing such that said segments project through said apertures when a force is applied to said member.
a housing having a plurality of apertures therein, a member having a plurality of expandable segments, said member cooperating with said housing such that said segments project through said apertures when a force is applied to said member.
19. The plug assembly of claim 18, said housing further comprising means for maintaining said segments in a projected configuration.
20. The plug assembly of claim 19, said means for maintaining said segments in said projected configuration comprising a groove in said housing and a flange onsaid member adapted to form a snap-fit with said groove.
21. The plug assembly of claim 20, said member further comprising a flange adapted to form a snap-fit with said groove.
22. The plug assembly of claim 18, said housing having curved indentations on the periphery thereof.
23. The plug assembly of claim 18, said housing further comprising a meatal plate.
24. The plug assembly of claim 23, said meatal plate having a thickness sufficient to withstand compression by the urethra.
25. The plug assembly of claim 18, said housing further comprising a membrane.
26. The plug assembly of claim 18, further comprising means for reversing the projection of said segments.
27. The plug assembly of claim 26, wherein said means for reversing the expansion comprises a cord.
28. A method for controlling urinary incontinence comprising:
a) providing a remove-to-void urethral plug assembly having an expandable housing and a solid element for mechanically expanding said housing, b) inserting said plug assembly into the natural opening of the urethra, c) exerting a force on said solid element for mechanically expanding said housing, wherein the force exerted is imposed by a wearer of the urethral plug assembly, d) mechanically expanding said housing via the force on said solid element impacting on said housing, until the flow of urine is blocked, e) reversing the mechanically expanded housing to return said housing to its non-expanded state, whereby said reversing is effectuated by the wearer, and f) removing the plug assembly from the natural opening of the urethra to allow the wearer to void the bladder.
a) providing a remove-to-void urethral plug assembly having an expandable housing and a solid element for mechanically expanding said housing, b) inserting said plug assembly into the natural opening of the urethra, c) exerting a force on said solid element for mechanically expanding said housing, wherein the force exerted is imposed by a wearer of the urethral plug assembly, d) mechanically expanding said housing via the force on said solid element impacting on said housing, until the flow of urine is blocked, e) reversing the mechanically expanded housing to return said housing to its non-expanded state, whereby said reversing is effectuated by the wearer, and f) removing the plug assembly from the natural opening of the urethra to allow the wearer to void the bladder.
29. The method of claim 28, further comprising;
expanding a sealing membrane while mechanically expanding said housing, whereby said solid element enables said sealing membrane to remain expanded notwithstanding a rupture of said sealing membrane.
expanding a sealing membrane while mechanically expanding said housing, whereby said solid element enables said sealing membrane to remain expanded notwithstanding a rupture of said sealing membrane.
30. The method of claim 28, further comprising;
manipulating a member coupled to said means for mechanically expanding said housing, for retraction of said expandable housing and removal of said plugassembly.
manipulating a member coupled to said means for mechanically expanding said housing, for retraction of said expandable housing and removal of said plugassembly.
31. A method for controlling urinary incontinence comprising:
a) providing a urethral plug assembly comprising a housing having apertures therein, and a solid element for mechanically expanding segments within said housing, b) inserting said plug assembly into the natural opening of the urethra, and c) exerting a force on said solid element for mechanically expanding said segments, so as to mechanically expand said segments through said apertures in said housing until the flow of urine is blocked.
a) providing a urethral plug assembly comprising a housing having apertures therein, and a solid element for mechanically expanding segments within said housing, b) inserting said plug assembly into the natural opening of the urethra, and c) exerting a force on said solid element for mechanically expanding said segments, so as to mechanically expand said segments through said apertures in said housing until the flow of urine is blocked.
32. The method according to claim 31, further comprising;
expanding a sealing membrane while mechanically expanding said segments.
expanding a sealing membrane while mechanically expanding said segments.
33. The method of claim 31, further comprising;
manipulating means for reversing the expansion of said elongated segments for removal of said plug assembly.
manipulating means for reversing the expansion of said elongated segments for removal of said plug assembly.
34. A plug assembly for use in the urethra to control urinary incontinence comprising:
a housing comprising a member having curved indentations on the periphery thereof to effect improved sealing of said housing with a wall of the urethra, a solid element for changing the shape of said member, means for reversing the changing of the shape of said member.
a housing comprising a member having curved indentations on the periphery thereof to effect improved sealing of said housing with a wall of the urethra, a solid element for changing the shape of said member, means for reversing the changing of the shape of said member.
35. A plug assembly for use in the urethra to control urinary incontinence comprising:
a housing adapted to be inserted into the natural opening of the urethra, including a meatal plate adapted to abut the urethral meatus, having a thicknesssufficient to withstand compression by the urethra, a solid element for mechanically changing the shape of said housing, means for reversing the changing of the shape of said housing.
a housing adapted to be inserted into the natural opening of the urethra, including a meatal plate adapted to abut the urethral meatus, having a thicknesssufficient to withstand compression by the urethra, a solid element for mechanically changing the shape of said housing, means for reversing the changing of the shape of said housing.
36. The plug assembly of claim 35, said meatal plate having a thickness of at least one millimeter.
37. A plug assembly for use in the urethra to control urinary incontinence, comprising:
a housing adapted to be inserted into the natural urethral opening of a wearer, a solid element for mechanically changing the shape of said housing, comprising a rod positioned within said housing and moveable within said housingto change the shape of said housing, means for reversing the changing of the shape of said housing.
a housing adapted to be inserted into the natural urethral opening of a wearer, a solid element for mechanically changing the shape of said housing, comprising a rod positioned within said housing and moveable within said housingto change the shape of said housing, means for reversing the changing of the shape of said housing.
38. A remove-to void device for blocking unwanted flow of urine comprising an expandable member, said member comprising a plastic polymer possessing a first shape prior to insertion into a human body, said first shape being insufficient in size and volume to form a plug to block the flow of urine and a second shape following insertion into said human body, said second shape being in response tothe environment of the urethra, bladder neck or bladder, said second shape forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as to remain in place against the walls of the urethra, bladder neck or bladder while blocking the flow of urine, said second shape occurring automatically without user intervention, wherein said member in said first shape is adapted to be configured in its non-expanded disposition, and in said second shape is adapted to be configured in its expanded disposition.
39. The device of claim 38, wherein said member further comprises a meatal plate.
40. The device of claim 39, wherein said meatal plate has a thickness sufficientto withstand compression by the urethra of said human.
41. The device of claim 40, wherein said thickness is at least 1 millimeter or greater.
42. The device of claim 38, wherein said device is inserted into said human body through a urethral meatus.
43. The device of claim 38, wherein said member in said second shape conforms to the shape of said human's urethra, bladder neck or bladder.
44. The device of claim 38, wherein said member is comprised of a compound which, prior to insertion of said device into the human body, indefinitely retains said first shape, and which, following insertion of said device into the human body, automatically without user intervention assumes said second shape in whichsaid member is greatly expanded relative to said first shape.
45. The device of claim 38, wherein said plastic polymer comprises polyurethane.
27a
27a
46. The device of claim 38, wherein said member is round in cross-section.
47. The device of claim 38, wherein said member further comprises radiused grooves in cross-section.
48. The device of claim 38, further comprises means for removal of said device.
49. The device of claim 48, wherein said means for removal is a tab.
50. The device of claim 48, wherein said means for removal is a cord.
51. A remove-to-void device for use in the urethra to control urinary incontinence comprising an expandable member, said member comprising a plastic polymer and being adapted to assume a first condition in which said member is relatively rigid and substantially tubular in configuration, said first condition being insufficient in size and volume to form a plug to block the flow of urine, said member being further adapted to assume a second condition in which said member becomes flexible and expandable in response to the environment of the urethra, bladder neck or bladder, said second condition forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as to remain in place against the walls of the urethra, bladder neck or bladder 27b while blocking the flow of urine, wherein said first condition exists prior to insertion of said device into a human body and said second condition exists automatically without user intervention following insertion of said device into the human body, the device further comprising a cord attached to said member, which when pulled by a wearer, allows said plug to be removed so that the wearer can void.
52. The device of claim 51, wherein said member further comprises a meatal plate.
53. The device of claim 52, wherein said meatal plate has a thickness sufficientto withstand compression by the urethra.
54. The device of claim 53, wherein said thickness is at least 1 millimeter or greater.
55. The device of claim 51, wherein said device is inserted into said human body through a urethral meatus.
56. The device of claim 51, wherein said member in said second condition conforms to the shape of said human body's urethra, bladder neck or bladder.
57. The device of claim 51, wherein said member is comprised of a compound which in said first condition, prior to insertion of said device into the human body, indefinitely retains said rigidity and said tubular configuration, and 27c which, following insertion of said device into the human body, assumes automatically without user intervention said second condition in which said member is greatly expanded relative to said first condition.
58. The device of claim 51, wherein said plastic polymer comprises polyurethane .
59. The device of claim 51, wherein said member is round in cross-section.
60. The device of claim 51, wherein said member further comprises radiused grooves in cross-section.
61. The device of claim 51, further comprising means for removal of said device.
62. The device of claim 61, wherein said removal means is a tab.
63. An automatically expanding, remove-to-void device for blocking unwanted flow of urine comprising a shaft substantially tubular in configuration having an expandable, deformable member at the proximal end of said shaft, said member comprising a plastic polymer and possessing a first shape prior to insertion into a human body, said first shape being sufficient in size and volume to form a plug to block the flow or urine, and a second shape following exposure to 27d bodily conditions in the environment of the urethra, bladder neck or bladder after insertion therein, said second shape forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as remain in place against the walls of the urethra, bladder neck or bladder while blocking the flow or urine, said second shape occurring automatically without user intervention, the device further comprising a cord attached to said shaft, which when pulled, allows a wearer to remove the device to void.
64. The device of claim 63, wherein said shaft further comprises a meatal plate.
65. The device of claim 64, wherein said meatal plate has a thickness sufficientto withstand compression by the urethra of said human body.
66. The device of claim 65, wherein said thickness is at least 1 millimeter or greater.
67. The device of claim 63, wherein said shaft is made of a biocompatible plastic polymer.
68. The device of claim 67, wherein said biocompatible plastic polymer is selected from the group consisting of thermoplastic elastomers, polyethylene polymers, polyurethane polymers, and nylon polymers.
27e
27e
69. The device of claim 63, further comprising means for removal of said device.
70. The device of claim 69, wherein said removal means is a tab.
71. A method for preventing an unwanted discharge of urine comprising the following steps:
(a) providing a remove-to-void expandable plug comprising a plastic polymer which can be inserted into a urethra, bladder neck or bladder of a human;
(b) inserting the expandable plug into the urethra, bladder neck or bladder of the human while the plug is in a first shape, said first shape being insufficient in size and volume to form a urine-impermeable barrier to the flow of urine;
(c) maintaining the plug in the urethra, bladder neck of bladder to allow expansion of the plug, said expansion occurring automatically and without user intervention, to form a second shape in response to the environment within the urethra, bladder neck or bladder, said second shape being of sufficient size andvolume to form a urine-impermeable barrier to the flow or urine, said second shape thereby retaining the plug in the urethra, bladder neck or bladder and restricting the flow of urine from the bladder through the urethra; and (d) removing the plug from the urethra, bladder neck or bladder to discharge the urine, by pulling on a cord attached 27f to said plug, which discharge could not be accomplished without removing said plug.
(a) providing a remove-to-void expandable plug comprising a plastic polymer which can be inserted into a urethra, bladder neck or bladder of a human;
(b) inserting the expandable plug into the urethra, bladder neck or bladder of the human while the plug is in a first shape, said first shape being insufficient in size and volume to form a urine-impermeable barrier to the flow of urine;
(c) maintaining the plug in the urethra, bladder neck of bladder to allow expansion of the plug, said expansion occurring automatically and without user intervention, to form a second shape in response to the environment within the urethra, bladder neck or bladder, said second shape being of sufficient size andvolume to form a urine-impermeable barrier to the flow or urine, said second shape thereby retaining the plug in the urethra, bladder neck or bladder and restricting the flow of urine from the bladder through the urethra; and (d) removing the plug from the urethra, bladder neck or bladder to discharge the urine, by pulling on a cord attached 27f to said plug, which discharge could not be accomplished without removing said plug.
72. A method for preventing an unwanted discharge of urine comprising the following steps:
(a) providing a remove-to-void device including an expandable member comprising a plastic polymer which can be inserted into the urethra, bladder neck or bladder of a human;
(b) inserting the remove-to-void device into the urethra, bladder neck or bladder of the human while the expandable member is in a first shape, said firstshape being insufficient in size and volume to form a urine-impermeable barrier to the flow of urine;
(c) maintaining the remove-to-void device in the urethra, bladder neck of bladder to allow expansion automatically without user intervention, of the member to form a second shape in response to the environment within the urethra, bladder neck or bladder, said second shape being of sufficient size and volume to form aurine-impermeable barrier to the flow of urine, said second shape thereby retaining the device in the urethra, bladder neck or bladder and restricting the flow of urine from the bladder through the urethra; and (d) removing the device from the urethra, bladder neck or bladder to discharge the urine, which discharge could not be accomplished without said removing of said plug.
(a) providing a remove-to-void device including an expandable member comprising a plastic polymer which can be inserted into the urethra, bladder neck or bladder of a human;
(b) inserting the remove-to-void device into the urethra, bladder neck or bladder of the human while the expandable member is in a first shape, said firstshape being insufficient in size and volume to form a urine-impermeable barrier to the flow of urine;
(c) maintaining the remove-to-void device in the urethra, bladder neck of bladder to allow expansion automatically without user intervention, of the member to form a second shape in response to the environment within the urethra, bladder neck or bladder, said second shape being of sufficient size and volume to form aurine-impermeable barrier to the flow of urine, said second shape thereby retaining the device in the urethra, bladder neck or bladder and restricting the flow of urine from the bladder through the urethra; and (d) removing the device from the urethra, bladder neck or bladder to discharge the urine, which discharge could not be accomplished without said removing of said plug.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/062,592 US5483976A (en) | 1990-12-31 | 1993-05-17 | Mechanically actuated urethral plug assembly and method for controlling urinary incontinence |
| US08/062,592 | 1993-05-17 | ||
| US8846993A | 1993-07-07 | 1993-07-07 | |
| US08/088,469 | 1993-07-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2163131A1 true CA2163131A1 (en) | 1994-11-24 |
Family
ID=26742459
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2163131 Abandoned CA2163131A1 (en) | 1993-05-17 | 1994-05-17 | Expandable urethral plug |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP0699060A4 (en) |
| AU (1) | AU6916094A (en) |
| CA (1) | CA2163131A1 (en) |
| WO (1) | WO1994026215A1 (en) |
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| US5724994A (en) * | 1990-12-31 | 1998-03-10 | Uromed Corporation | Fluidly expandable urethral plug assembly which receives fluid from an external source and method for controlling urinary incontinence |
| WO1995034253A1 (en) * | 1994-06-14 | 1995-12-21 | Iotek, Inc. | Incontinence treatment |
| US5701914A (en) * | 1995-10-31 | 1997-12-30 | Loeffler; Charles P. | Male contraceptive |
| US5722931A (en) * | 1996-03-05 | 1998-03-03 | Urohealth Systems, Inc. | Female incontinence device |
| US5906575A (en) * | 1996-04-25 | 1999-05-25 | Rochester Medical Corporation | Urethral urine retention device |
| EP0821919A3 (en) * | 1996-07-29 | 1999-06-09 | VIA LOG Medikalprodukte GmbH Kosmetik - Medien | Closure for urethra |
| US6200261B1 (en) | 1998-03-04 | 2001-03-13 | American Medical Systems, Inc. | Valve and methods for urinary control |
| FR2843876B1 (en) | 2002-08-30 | 2004-11-26 | Bernard Bouffier | SURGICAL PROSTHESIS DEVICE FOR THE IMPLANTATION OF A SUPPORT OF A MAMMALIAN BODY |
| US8864730B2 (en) | 2005-04-12 | 2014-10-21 | Rochester Medical Corporation | Silicone rubber male external catheter with absorbent and adhesive |
| US7553273B2 (en) | 2006-05-01 | 2009-06-30 | Duodyn Technology, Llc | Apparatus and method for managing incontinence |
| US8617045B2 (en) | 2006-08-15 | 2013-12-31 | International Medical Technology, Inc. | Urinary incontinence device |
| DE102008022332B4 (en) | 2008-04-29 | 2021-03-25 | Karl Storz Se & Co. Kg | Medical instrument for dilating the paranasal sinuses |
| US9707375B2 (en) | 2011-03-14 | 2017-07-18 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
| US20130079589A1 (en) * | 2011-09-22 | 2013-03-28 | Coloplast A/S | Incontinence treatment device configured for urethral placement into the bladder |
| US10092728B2 (en) | 2012-11-20 | 2018-10-09 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Sheath for securing urinary catheter |
| US9872969B2 (en) | 2012-11-20 | 2018-01-23 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Catheter in bag without additional packaging |
| WO2016033234A1 (en) | 2014-08-26 | 2016-03-03 | C.R. Bard, Inc | Urinary catheter |
| CN106510786A (en) * | 2016-11-29 | 2017-03-22 | 西安医学院第二附属医院 | Compression hemostasis apparatus for anus wound part |
| EP3675779A4 (en) | 2017-09-19 | 2020-07-08 | C.R. Bard, Inc. | Urinary catheter bridging device, systems and methods thereof |
| US11246693B2 (en) | 2019-09-18 | 2022-02-15 | David Hesse | Urinary plug device |
| US11583666B2 (en) | 2019-09-18 | 2023-02-21 | David Hesse | Device and methods for treating urothelial conditions |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3841304A (en) * | 1972-10-16 | 1974-10-15 | A Jones | Inflatable leakage inhibitor |
| EP0193406B1 (en) * | 1985-02-28 | 1991-02-20 | Medtronic, Inc. | Device for controlling incontinence |
| US4979947A (en) * | 1985-10-10 | 1990-12-25 | Berman Irwin R | Encapsulated expandible continence device |
| GB8713938D0 (en) * | 1987-06-15 | 1987-07-22 | West H R | Female urinary incontinence devices |
| US4846784A (en) * | 1987-07-01 | 1989-07-11 | C. R. Bard, Inc. | Manually adjustable sphincteric system |
| DK77491A (en) * | 1991-04-25 | 1992-10-26 | Tage Wenzel Debess | SELF-ADJUSTING PRESSURE-COMPENSATING DEVICE WITH THE PURPOSE OF PREVENTING THE IMPROPER DISPOSAL OF URINE, INCLUDING INCONTINENCE, PRIOR TO WOMEN |
-
1994
- 1994-05-17 EP EP94917427A patent/EP0699060A4/en not_active Withdrawn
- 1994-05-17 CA CA 2163131 patent/CA2163131A1/en not_active Abandoned
- 1994-05-17 WO PCT/US1994/005536 patent/WO1994026215A1/en not_active Application Discontinuation
- 1994-05-17 AU AU69160/94A patent/AU6916094A/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU6916094A (en) | 1994-12-12 |
| WO1994026215A1 (en) | 1994-11-24 |
| EP0699060A1 (en) | 1996-03-06 |
| EP0699060A4 (en) | 1997-05-21 |
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| Date | Code | Title | Description |
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| FZDE | Dead |